Mycotic/Infective Native Aortic Aneurysms: Results After Preferential Use of Open Surgery and Arterial Allografts.

OBJECTIVE: Mycotic/infective native aortic aneurysms (INAA) are managed heterogeneously. In the context of disparate literature, this study aimed to assess the outcomes of INAA surgical management and provide comprehensive data in alignment with recent suggestions for reporting standards. METHODS: A retrospective review of patients presenting with INAA from September 2002 to March 2020 at two institutions was conducted. In hospital mortality, 90 day mortality, overall mortality, and infection related complications (IRCs) were the study endpoints. Overall survival and IRC free survival were estimated, and predictors of mortality tested using uni- and multivariable analyses. RESULTS: Seventy patients (60 men [86%], median age 68 years [range 59 - 76 years]) were included. Twenty (29%) were ruptured at presentation. INAA location was thoracic in 11 (16%) cases, thoraco-abdominal in seven (10%), and abdominal in 50 (71%). Half of the abdominal INAAs were suprarenal. Two INAAs were concomitantly abdominal and thoracic. Pathogens were identified in 83%. The bacterial spectrum was scattered, with rare Salmonella species (n = 6; 9%). Open surgical repair was performed in 66 (94%) patients, including five conversions of initially attempted endovascular grafts (EVAR), three hybrid procedures, and one palliative EVAR. Vascular substitutes were cryopreserved arterial allografts (n = 67; 96%), prosthesis (n = 2), or femoral veins (n = 1). Kaplan-Meier estimates of overall survival at 30 and 90 days were 87% (95% confidence interval [CI] 76.6 - 93.0) and 71.7% (95% CI 59.2 - 80.9), respectively. The overall in hospital mortality rate was 27.9% (95% CI 1.8 - 66.5). IRCs occurred in seven (10%) patients. The median follow up period was 26.5 months (range 13.0-66.0 months). Chronic kidney disease (CKD) was independently related to in hospital mortality (odds ratio [OR] 20.7, 95% CI 1.8 - 232.7). American Society of Anesthesiologists score of 3 (OR 6.0, 95% CI 1.1 - 33.9), 4 (OR 14.9, 95% CI 1.7 - 129.3), and CKD (OR 32.0, 95% CI 1.2 - 821.5) were related to 90 day mortality. CONCLUSION: Surgical INAA management has significant mortality and a low re-infection rate. EVAR necessitated secondary open repair, but its limited use in this report did not allow conclusions to be drawn.

A Model for Early Endoscopic Detection of High-Risk Gastroesophageal Varices in Children With Biliary Atresia.

OBJECTIVE: In children with biliary atresia and portal hypertension, progression to gastroesophageal varices carrying a risk of bleeding depends on age, total serum bilirubin concentration and initial endoscopic features. We report an attempt to use these factors for early detection of high-risk varices (HRVs). METHODS: Based on different combinations of these factors, a model was set to estimate the probabilities of emergence of HRVs at various time intervals. A 10% probability was chosen to set the date of the next endoscopy in children who did not display HRVs initially. A total of 113 children without HRVs who underwent their first endoscopy before age 8 in 2013-2020 were included. A comparison was made with children seen during the period 1990-2012 when this model was not used. RESULTS: In all, 65 of the 113 children underwent one to five additional endoscopies at dates set according to the model. The emergence of HRVs was recorded in 22 children after a mean interval of 14 months and was managed by endoscopic primary prophylaxis in all but one who underwent liver transplantation. Three other children bled before the next planned endoscopy. Compared with 175 children of the same age ranges without HRVs in the period 1990-2012, the use of the model was associated with a faster detection of HRVs with a lower number of endoscopic procedures (P  = 0.0022 and P  = 0.023, respectively). CONCLUSION: The results suggest that the model reported may be a useful tool for the early detection of HRVs to allow primary prophylaxis of bleeding.

Is bridging vein rupture/thrombosis associated with subdural hematoma at birth?

BACKGROUND: The combination of bridging vein rupture/thrombosis and subdural hematoma in infants has recently gained attention as highly suggestive of abusive head trauma. While subdural hematomas are frequently observed at birth, there are no previous studies of bridging vein rupture/thrombosis prevalence in that context. OBJECTIVE: To evaluate the prevalence of bridging vein rupture/thrombosis in newborns with and without subdural hematoma. MATERIALS AND METHODS: This bicentric retrospective study (2012-2019) looked at all brain MRIs performed in neonates. We noted delivery method, demographic data and intracranial injuries and analyzed any clots at the vertex as potential markers of bridging vein rupture/thrombosis. RESULTS: We analyzed 412 MRIs in 412 neonates. Age was (mean ± standard deviation [SD]) 5.4±2.2 days and 312 (76%) infants were full term (38.3±2.9 weeks from last menstrual period). The delivery method was vaginal birth for 42% (n=174), cesarean section for 43% (n=179), and unknown for 14% (n=59). Subdural hematoma was present in 281 MRIs (68.0%, [95% confidence interval = 63.3-72.5]). Six MRIs showed at least one clot at the vertex, assumed to be possible bridging vein rupture/thrombosis (1.5%, [0.5-3.1%]). Only one MRI showed more than two clots at the vertex, in a context of maternal infection. There was no significant difference in terms of gestational age at birth, delivery method or the presence of subdural hematoma or parenchymal injuries between those 6 infants and the 406 others. CONCLUSION: Bridging vein rupture/thrombosis at birth is very rare and unlikely to be related to subdural hematoma.

Being useful among persons aged over 65: social representations from a cross-sectional European study.

BACKGROUND: There is a compelling need to prepare our societies and healthcare systems to deal with the oncoming wave of population ageing. The majority of older persons maintain a desire to be valued and useful members of society and of their social networks. AIMS: We sought to investigate the perception of usefulness among persons aged 65 years and over in four European countries. METHODS: We performed a cross-sectional survey with a representative sample of individuals aged 65 years or older from the population of retired persons (including recently retired persons and oldest-old individuals) from 4 European countries selected using quota sampling. In February 2016, an internet questionnaire was sent to all selected individuals. The characteristics used for the quota sampling method were sex, age, socio-professional category, region, city size, number of persons in household, autonomy, marital status, place of residence, income and educational status. The questionnaire contained 57 questions. Sociodemographic characteristics were recorded. Responses were analysed with principal components analysis (PCA). RESULTS: A total of 4025 persons participated; 51% were males, and 70% were aged 65-75 years. PCA identified six classes of individuals, of which two classes (Classes 2 and 3) were characterized by more socially isolated individuals with little or no sense of usefulness, low self-esteem and a poor sense of well-being. These two classes accounted for almost 20% of the population. Younger and more autonomous classes reported a more salient sense of usefulness. CONCLUSIONS: The loss of the sense of usefulness is associated with dissatisfaction with life and a loss of pleasure, and persons with profiles corresponding to Classes 2 and 3 should, therefore, be targeted for interventions aimed at restoring social links.

Intraoperative adverse events and early outcomes of custom-made fenestrated stent grafts and physician-modified stent grafts for complex aortic aneurysms.

OBJECTIVE: Physician-modified fenestrated stent grafts (PMSGs) are a useful option for urgent or semiurgent treatment of complex abdominal aortic aneurysms (CAAAs). The aim of this study was to describe in-hospital outcomes of custom-made fenestrated stent grafts (CMSGs) and PMSGs for the treatment of CAAAs and thoracoabdominal aortic aneurysms (TAAAs). METHODS: In this single-center, retrospective study, all consecutives patients with CAAAs or TAAAs undergoing endovascular repair using Zenith CMSGs (Cook Medical, Bloomington, Ind) or PMSGs between January 2012 and November 2017 were included. End points were intraoperative adverse events, in-hospital mortality, postoperative complications, reinterventions, target vessel patency, and endoleaks. RESULTS: Ninety-seven patients were included (CMSGs, n = 69; PMSGs, n = 28). The PMSG group included more patients assigned to American Society of Anesthesiologists class 4 (n = 14 [50%] vs n = 16 [23%]; P = .006) and more TAAAs (n = 17 [61%] vs n = 10 [15%]; P < .0001). Intraoperative adverse events were recorded in eight (11%) patients in the CMSG group vs six (21%) patients in the PMSG group. No intraoperative death or open conversion occurred. In-hospital mortality rates were of 4% (n = 3) in the CMSG group and 14% in the PMSG group (n = 4). Chronic renal failure was an independent preoperative risk factor of postoperative death or complications (odds ratio, 4.88; 95% confidence interval, 1.65-14.43; P = .004). Rates of postoperative complications were 22% (n = 15) and 25% (n = 7) in the CMSG and PMSG groups. Spinal cord ischemia rates were 4% (n = 3) and 7% (n = 2) in the CMSG and PMSG groups. Reintervention rates were 16% (n = 11) in the CMSG group and 32% (n = 9) in the PMSG group. At discharge, target vessel patency rate in CMSGs was 98% (n = 207/210). All target vessels (n = 98) were patent in the PMSG group. Endoleaks at discharge were observed in 24% of the CMSG group (n = 16) vs 8% of the PMSG group (n = 2). CONCLUSIONS: Our study showed clinically relevant differences of several important in-hospital outcomes in the CMSG and PMSG groups. Larger cohorts and longer follow-up are needed to allow direct comparison. PMSGs may offer acceptable in-hospital results in patients requiring urgent interventions when CMSGs are not available or possible.

Temozolomide Alone or Combined with Capecitabine for the Treatment of Advanced Pancreatic Neuroendocrine Tumor.

BACKGROUND: The combination of capecitabine (CAP) with temozolomide (TEM) chemotherapy in advanced pancreatic neuroendocrine tumors (PanNET) relies on limited evidence. We compared TEM-CAP to TEM alone in patients with advanced PanNET. METHODS: Consecutive patients with advanced PanNET treated with TEM or TEM-CAP between 2004 and 2017 in three expert centers were included. Progression-free survival (PFS), tolerance, tumor response, and overall survival were compared between the two groups. Propensity-based analyses were performed to reduce confounding bias due to the nonrandomized setting. RESULTS: TEM and TEM-CAP were administered to 38 patients and 100 patients, respectively, with a median age of 58 years. The patients in the TEM group more often had hormonal syndromes (p = 0.03), a longer median delay to diagnosis (p = 0.001), and a higher number of pretreatment lines (p < 0.001). The performance status was 0 in 58% versus 65% of the patients, and tumor's median Ki-67 index was 8% versus 11%, respectively. Tolerance was similar, except that there were more cases of asthenia in the TEM group (p = 0.017) and more cases of hand-foot syndrome in the TEM-CAP group (p = 0.025). The objective response rate was 34% versus 51% (p = 0.088). The raw median PFS was similar with TEM and with TEM-CAP (21.4 vs. 19.8 months, p = 0.84). Although CAP tended to decrease the risk of progression in Cox multivariate analysis (HR 0.65, p = 0.12), it had no effect after adjustment for the propensity score (HR 1.06, p = 0.80). CONCLUSIONS: TEM-CAP might not prolong PFS but might achieve a higher response rate than TEM alone. Hence, TEM-CAP might be preferred when tumor shrinkage is the main therapeutic objective. Otherwise, TEM might be adequate for patients with an impaired performance status or in case of extrahepatic metastases.

Classic Metaphyseal Lesions among Victims of Abuse.

OBJECTIVE: To use legal statements by perpetrators to gain new insights into the causative mechanism of classic metaphyseal lesion (CML). The CML, so called "corner fracture," is considered a highly specific marker for abuse in infants. However, the precise correlation between CMLs and abusive head trauma is still unknown. STUDY DESIGN: In this retrospective observational study, we selected 67 cases with at least 1 CML from a 15-year cohort of legally prosecuted child abuse cases. Their clinical, radiologic, and forensic records were analyzed. In 27 cases, the perpetrator confessed to abusing the child and described the events. Potential associations with subdural hematoma and with confession were evaluated using 2 separate binary logistic regression models. RESULTS: All 67 infants showed other signs of abuse. Median age was 3.4 months. Over 65% had multiple CMLs. Knees and ankles were predominantly involved (64%). Only CMLs of the shoulder were significantly associated with subdural hematoma (P = .03). Different-age fractures were more common in the nonsubdural hematoma group (P = .01). In the group with confessions, perpetrators admitted inflicting violent indirect skeletal forces (torsion, traction, compression, and forced movements). The most common circumstance was diapering (44%), reported by male perpetrators only (P = .03) followed by dressing/undressing (30%). The violence was habitual in 67% of cases. CONCLUSIONS: This unique forensic case series shows that CMLs are caused by violent acts inflicted most during physical care of infants. The frequency of habitual violence responsible for CMLs deserves greater attention.

Comparison of Temozolomide-Capecitabine to 5-Fluorouracile-Dacarbazine in 247 Patients with Advanced Digestive Neuroendocrine Tumors Using Propensity Score Analyses.

INTRODUCTION: Although chemotherapy combining 5-fluorouracil (5FU)-dacarbazine (DTIC) or temozolomide (TEM)-capecitabine (CAP) is extensively used in patients with neuroendocrine tumors (NET), they were never compared. We compared their tolerance and efficacy in advanced NET. METHODS: We evaluated the records of consecutive patients with pancreatic or small-intestine advanced NET who received 5FU-DTIC or TEM-CAP between July 2004 and December 2017 in 5 French centers. Tolerance, tumor response and progression-free survival (PFS) were compared. Factors associated with PFS were analyzed using Cox multivariate regression model. To reduce the confounding bias of the nonrandomized design, PFS was compared using propensity score analyses. RESULTS: Ninety-four (5FU-DTIC) patients and 153 (TEM-CAP) patients were included. Pancreatic NET represented 82.3% of cases and 17.1, 61.8 and 10.9% of patients had G1, G2 or G3 NET respectively. Progression at baseline was reported in 92.7% of patients with available data. Grades 3-4 adverse events occurred in 24.7 and 8.5% of TEM-CAP and 5FU-DTIC patients respectively (p = 0.002). The overall response rate was 38.3 and 39.2% respectively (p = 0.596). Median PFS on raw analysis was similar to 5FU-DTIC and TEM-CAP (13.9 vs. 18.3 months, respectively p = 0.86). TEM-CAP was associated with an increased risk of progression on the raw multivariate analysis (hazard ratio [HR] 1.90, 95% CI [1.32-2.73], p = 0.001) and when adjusted on propensity score (HR 1.65, 95% CI [1.18-2.31], p = 0.004). CONCLUSION: PFS may be longer with 5FU-DTIC than TEM-CAP in patients with advanced NET. Although patients often prefer oral chemotherapy, 5FU-DTIC is a relevant alternative. A randomized comparison is needed to confirm these results.

Geometric modification of the humeral position after total reverse shoulder arthroplasty: what is the optimal lowering of the humerus?

BACKGROUND: The main mechanical effect after reverse shoulder arthroplasty (RSA) is the lowering of the glenohumeral rotation center. The optimal value of the humeral lowering after RSA is still debated. The main objective of our study was to determine the lowering and medialization of the humerus and to correlate these parameters with short-term functional results. MATERIALS AND METHODS: The study included 70 patients with complete radiographic and clinical data. A multivariate analysis was used to compare the clinical and radiographic outcomes with the humeral lowering. RESULTS: The mean humeral lowering was 25.4 mm (range, 6-38 mm), and the mean medialization was 9.2 mm (range, 0-20 mm). Humeral lowering significantly influenced active forward elevation and the rate of scapular notching. DISCUSSION: The best clinical results and the lowest incidence of scapular notching were found after a lowering of more than 24 mm in our series. We recommend humeral lengthening of at least 24 mm after implanting a total reverse shoulder prosthesis.

Reproducibility of a new method for measuring lowering and medialisation of the humerus after reverse shoulder arthroplasty.

BACKGROUND: Reverse shoulder arthroplasty (RSA) requires lowering the humerus and medialisation of the centre of rotation. Several techniques based on standard X-rays are available in the literature. The aim of this study was to expose and validate a new technique for measuring these parameters. MATERIALS AND METHODS: Radiographic data of 20 patients were included. Three observers examined each X-rays three times to establish the inter- and intra-reproducibility of each technique (Jobin, Renaud and our method). RESULTS: Intra-observer reproducibility was between 0.10 and 0.94. The best intra-observer intraclass correlation coefficient (ICC) was obtained using Renaud's and our techniques. The inter-observer reproducibility was between 0.37 and 0.74. The best inter-observer ICC was obtained with our technique. DISCUSSION: We describe a reliable and reproducible method to evaluate lowering and medialisation of the humerus after RSA. This technique may allow determine the optimal threshold of lengthening after RSA.

Adjudication of osteonecrosis of the jaw in phase III randomized controlled trials of denosumab: a systematic review.

PURPOSE: Denosumab (an anti RANKL antibody) is known to be associated with an increased risk for osteonecrosis of the jaw (ONJ). Due to the variety of clinical presentation, many ONJ definitions are used. Evaluation of ONJ's frequency during phase III randomized controlled trials (RCTs) is crucial to assess benefit-risk ratio. We verified that phase III RCTs involving denosumab reported the definition of ONJ used. METHODS: We systematically searched in Central, Medline, Cochrane, and Scopus, until 31 August 2015. We included original phase III RCTs, involving denosumab. Post hoc analysis and trial extension were excluded. Articles that did not mention ONJ in their methods or results were excluded. The primary outcome was the prevalence of a complete definition of ONJ. When no definition was provided, ONJ adjudication process was analyzed. RESULTS: Of 313 articles found, 13 RCTs were included. A definition of ONJ was detailed in two RCTs (15%). For the remaining 11 RCTs, adjudication process was mentioned for nine. In those processes, "blinded," "expert," and "independent" were the most used words. CONCLUSION: Most of the published phase III RCTs involving denosumab did not specify the definition of ONJ used to adjudicate events in the study. Instead of definition, non-scientific and non-reproducible expressions were used. Because the chosen definition could impact the ONJ estimated frequency, it should be mandatory to give the precise definition used in each RCT publication involving denosumab.

National trends in use and costs of oral anticancer drugs in France: An 8-year population-based study.

PURPOSE: During the last decade, many oral anticancer drugs (OAcDs) have been marketed, providing interesting but potentially costly pharmaceutical alternatives to intravenous treatments. This study aims to provide updated information on their use and costs. METHODS: A cross-sectional yearly repeated study was conducted from 2006 to 2014 using the representative sample of the French national health care insurance system claims database (EGB). OAcD use was described for each year, among prevalent (ie, patients with at least 1 OAcD reimbursement) and incident users (ie, patients with no OAcD reimbursement within the prior year) and according to their pharmacological classes (Hormone Therapy [HT], Cytotoxic Therapy [CT], Targeted Therapy [TT], and others). Demographic characteristics were described for both users; comorbidities and direct medical costs were described for incident users only. RESULTS: The yearly prevalence and incidence of OAcD use, mainly represented by HT, remained stable from 2006 to 2014 (1.2%; 0.4%). Compared with users of other OAcD classes, the proportion of TT users substantially increased over the 8-year study period (+9.3%), and TT incident users had more severe comorbidities at treatment initiation. The health expenditures were the most important in TT users with median monthly medical direct costs varying from 2995€ to 4968€ per patient between 2006 and 2014. CONCLUSION: With the development of new OAcDs, the TTs use reaches a wider population of patients but is responsible for increasing health expenditures.

Computer-assisted study of the axial orientation and distances between renovisceral arteries ostia.

PURPOSE: Endovascular navigation in aortic, renal and visceral procedures are based on precise knowledge of arterial anatomy. Our aim was to define the anatomical localization of the ostia of renovisceral arteries and their distribution to establish anatomical landmarks for endovascular catheterization. METHODS: Computer-assisted measurements performed on 55 CT scans and patients features (age, sex, aortic diameter) were analyzed. p values <0.05 were considered statistically significant. RESULTS: The mean axial angulation of CeT and the SMA origin was 21.8° ± 10.1° and 9.9° ± 10.5°, respectively. The ostia were located on the left anterior edge of the aorta in 96 % of cases for the CeT and 73 % for the SMA. CeT and SMA angles followed Gaussian distribution. Left renal artery (LRA) rose at 96° ± 15° and in 67 % of cases on the left posterior edge. The right renal artery (RRA) rose at -62° ± 16.5° and in 98 % of cases on the right anterior edge of the aorta. RRA angle measurements and cranio-caudal RRA-LRA distance measurements did not follow Gaussian distribution. The mean distances between the CeT and the SMA, LRA, and RRA were 16.7 ± 5.0, 30.7 ± 7.9 and 30.5 ± 7.7 mm, respectively. CeT-SMA distance showed correlation with age and aortic diameter (p = 0.03). CeT-LRA distance showed correlation with age (p = 0.04). The mean distance between the renal ostia was 3.75 ± 0.21 mm. The RRA ostium was higher than the LRA ostium in 52 % of cases. RRA and LRA origins were located at the same level in 7 % of cases. CONCLUSION: Our results illustrate aortic elongation with ageing and high anatomical variability of renal arteries. Our findings are complementary to anatomical features previously published and might contribute to enhance endovascular procedures safety and efficacy for vascular surgeons and interventional radiologists.

[Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center]. / Les effets indésirables médicamenteux en pédiatrie : expérience d'un centre régional de pharmacovigilance.

AIM: To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. METHODS: An observational study on all ADR notifications recorded in the French pharmacovigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics. RESULTS: During the study period, 632 notifications were collected. The most frequently reported ATC (anatomical, therapeutic and chemical) classes were vaccines (15.9%), antineoplastics (12%) and antibiotics (11.1%). Forty-six percent of the notifications were serious. For serious ADRs, the most involved drugs were paracetamol, asparaginase and ibuprofen. Skin reactions were the most often reported ADRs. The most common lowest level terms (LLT) were urticaria (4.9%), hypersensitivity (4.1%), fever (2.9%) and vomiting (2.8%). CONCLUSION: ADR reporting to the pharmacovigilance system, in particular pediatric ADRs, should be encouraged. Information on the use of medicinal products, especially on self-medication use, need to be improve.

[Information and communication technology and health of the elderly]. / Technologies de l'information et de la communication et santé des seniors.

New technologies offer many advantages, especially in terms of animation in elderly care homes. Consoles and digital tablets used without any medical implication were the subject of a literature review on their impact on the health of the elderly..

Prognostic factors in operable breast cancer treated with neoadjuvant chemotherapy: towards a quantification of residual disease.

OBJECTIVE: Neoadjuvant chemotherapy (NACT) allows for a more frequent use of breast-conservative surgery; it is also an in vivo model of individual tumor sensitivity which permits to determine new prognostic factors to personalize the therapeutic approach. METHODS: Between 2000 and 2012, 318 patients with primary invasive breast cancer were treated with a median of 6 cycles of NACT; they received either an anthracycline-based FEC 100 protocol (31.1%), or anthracyclines + taxanes (53.5%), with trastuzumab if indicated (15.4%). RESULTS: After a median follow-up of 44.2 months, the pathological complete response rate according to the classification of Chevallier et al. [Am J Clin Oncol 1993;16:223-228] was 19.3%, and overall (OS) and disease-free survival (DFS) at 10 years were 60.2 and 69.6%, respectively. Univariate analyses demonstrated that the Residual Disease in Breast and Nodes (RDBN) index was the most significant prognostic factor for OS (p = 0.0082) and DFS (p = 0.0022), and multivariate analyses mainly revealed that the residual tumor size, residual involved node number and post-chemotherapy Scarff-Bloom-Richardson (SBR) grading were the most significant prognostic factors. CONCLUSIONS: In a cohort of patients who were all homogeneously treated with some of the most common drugs for breast cancer, we demonstrate that NACT may provide additional prognostic factors and confirm the RDBN index. As this index allows for the prediction of survival with different breast cancer subtypes, we suggest that it should be calculated routinely to help clinicians to select patients who need adjuvant treatments.

[Not Available]. / Les effets indésirables médicamenteux graves et leur évitabilité chez des sujets âgés de plus de 65 ans.

AIM: To describe the serious adverse drug reactions (ADR) in elderly subjects aged over 65 years and assess their preventability. METHODS: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study. RESULTS: Over the study period, 100 subjects were included in the study. The sex ratio was 0.96. Twenty seven percent of serious ADR were preventable. Off-label use accounted for 20% and non-compliance for 5%. Bleeding events were the most common serious ADR (36%). The drugs most frequently involved in serious ADR were antithrombotic agents (31.4%). CONCLUSION: More than a quarter of serious ADR were preventable. Off-label use and non-compliance are the main causes identified in the occurrence of preventable serious ADR.

[Serious Adverse Drug Reaction and Their Preventability in the Elderly Over 65 Years]. / Les effets indésirables médicamenteux graves et leur évitabilité chez des sujets âgés de plus de 65 ans.

AIM: To describe the serious adverse drug reactions (ADR) in elderly subjects aged over 65 years and assess their preventability. METHODS: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study. RESULTS: Over the study period, 100 subjects were included in the study. The sex ratio was 0.96. Twenty seven percent of serious ADR were preventable. Off-label use accounted for 20% and non-compliance for 5%. Bleeding events were the most common serious ADR (36%). The drugs most frequently involved in serious ADR were antithrombotic agents (31.4%). CONCLUSION: More than a quarter of serious ADR were preventable. Off-label use and non-compliance are the main causes identified in the occurrence of preventable serious ADR.